The Micro Therapeutics, Inc. Over the Wire (OTW) Thrombolytic Brush Catheter is intended for percutaneous dissolution of acute thrombus located in arteriovenous (A-V) fistula. The Over the Wire (OTW) Thrombolytic Brush Catheter is designed to augment the area of interface between clot and pharmacologic augment by simultaneous thrombolysis and clot maceration. Clinical studies demonstrate effective dissolution of thrombus in A-V grafts when this product is used in conjunction with urokinase. The Over the Wire (OTW) Thrombolytic Brush Catheter is not intended for use in native vessels. The device should not be used on patients with a history of significant pulmonary disease of pulmonary hypertension.

Device Description

The Micro Therapeutics, Inc. Over the Wire (OTW) Thrombolytic Brush Catheter is intended for the percutaneous dissolution of acute thrombus located in artificial The OTW Thrombolytic Brush Catheter is designed to arteriovenous (A-V) fistula. augment the area of interface between clot and pharmacologic agent by simultaneous thrombolysis and clot maceration. The integral system utilizes a catheter with proximal Yconnector, a soft brush attached at the distal end of a hollow drive shaft, and a hand-held battery-powered motor drive.

AI/ML Overview

The provided 510(k) summary (K973664/K973669) describes the Micro Therapeutics, Inc. Over the Wire (OTW) Thrombolytic Brush Catheter. This submission establishes substantial equivalence to a predicate device, the Thrombolytic Brush Catheter (K963925) also manufactured by Micro Therapeutics, Inc., rather than providing a performance study against specific acceptance criteria for a novel device. Therefore, a table with acceptance criteria and reported device performance, and details of studies involving human readers, training sets, and ground truth establishment, are not applicable in the typical sense for this submission.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Not explicitly provided as acceptance criteria for a novel device. The submission focuses on demonstrating equivalence to a predicate device through a series of tests. The "performance" is inferred to be "equivalent" to the predicate.

Acceptance Criteria (Implied Equivalence to Predicate)	Reported Device Performance
Dimensional characteristics equivalent to predicate device	In vitro tests confirmed dimensional measurements.
Bristle and wire cable strength equivalent to predicate device	In vitro tests confirmed bristle and wire cable strength characterization.
Motor drive integrity equivalent to predicate device	In vitro tests confirmed motor drive integrity testing.
Catheter flow rates equivalent to predicate device	In vitro tests confirmed catheter flow rates.
Bond strengths equivalent to predicate device	In vitro tests confirmed bond strengths.
Burst pressure equivalent to predicate device	In vitro tests confirmed burst pressure.
Performance under simulated conditions equivalent to predicate device	In vitro tests confirmed performance under simulated conditions.
Electromagnetic and patient safety equivalent to predicate device	Independent laboratory tests covered electromagnetic and leakage current potential.
In vivo performance in dissolving thrombus in A-V fistulas equivalent to predicate device	In vivo animal studies demonstrated OTW Thrombolytic Brush Catheter performed the same as the predicate device.
Biocompatibility compliant with standards	All components tested per ISO 10993-1.

2. Sample Size Used for the Test Set and Data Provenance:

In Vitro Tests: "Sample sterile devices were subjected to extensive physical bench testing." No specific number of samples is provided.
In Vivo Tests: "In vivo animal tests were performed..." No specific number of animals is provided for the test set. Given it's animal testing, the data provenance is presumably from the testing facility where the study was conducted; it is not stated as retrospective or prospective in relation to human data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. The studies performed were bench tests and animal studies, not human clinical studies requiring expert ground truth for interpretation of outcomes.

4. Adjudication Method for the Test Set:

Not applicable. There are no human readers or subjective interpretations that would require an adjudication method. The tests are objective measurements and observations in laboratory and animal settings.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a mechanical catheter and does not involve AI or human image interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is not an algorithm. Its performance is assessed through physical and biological tests.

7. The type of ground truth used:

In Vitro Tests: The "ground truth" was based on established engineering specifications, physical integrity, and performance metrics for medical devices, implicitly benchmarked against the predicate device's characteristics.
In Vivo Tests: The "ground truth" was the observed performance of the device in dissolving thrombus in A-V fistulas within the animal model, compared directly to the predicate device's performance.

8. The Sample Size for the Training Set:

Not applicable. This product is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this type of device submission.

Summary

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K973664

Image /page/0/Picture/2 description: The image shows the logo for Micro Therapeutics, Inc. The logo consists of the letters "MTI" in a bold, stylized font, with a series of small squares arranged in a grid pattern to the left of the letters. To the right of the letters is the full name of the company, "MICRO THERAPEUTICS, INC.", in a smaller, but still legible, font.

1062-F Calle Negocio San Clemente, CA 92673 Tel. 714-361- 0616 Fax 714- 361-0210

510(k) SUMMARY

Contact Person

Jack Gehrich Vice President of Regulatory & Clinical Affairs

Trade Name

Over the Wire (OTW) Thrombolytic Brush Catheter

Common Name

Thrombectomy Catheter Infusion Catheter

Classification Name

Percutaneous Catheter (per 21 CFR 870.1250)

Substantially Equivalent Devices

Thrombolytic Brush Catheter (Micro Therapeutics)

Description

Intended Use

The Micro Therapeutics, Inc. Over the Wire (OTW) Thrombolytic Brush Catheter is intended for percutaneous dissolution of acute thrombus (i.e., less than two weeks old) located in arteriovenous (A-V) fistula utilizing a .035" guide wire for tracking and positioning within the fistula. The OTW Thrombolytic Brush Catheter is designed to augment the area of interface between clot and pharmacologic augment by simultaneous thrombolysis and clot maceration. Clinical studies demonstrate effective dissolution of thrombus in A-V grafts when this product is used in conjunction with urokinase. The OTW Thrombolytic Brush Catheter is not intended for use in native vessels. The device should not be used on patients with a history of significant pulmonary disease or pulmonary hypertension.

00046

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510(k) SUMMARY (cont.)

Technological Characteristics

This product is equivalent in intended use, as well as dimensional characteristics, composition and function to the legally marketed Thrombolytic Brush Catheter, (K963925) manufactured by Micro Therapeutics, Inc.

Summary of Studies

Performance Data

In Vitro Tests

Sample sterile devices were subjected to extensive physical bench testing. In vitro tests were conducted which included dimensional measurements, bristle and wire cable strength characterization, motor drive integrity testing, catheter flow rates, bond strengths, burst pressure and performance under simulated conditions. Additionally, electromagnetic and patient safety tests were conducted by an independent laboratory to evaluate the electromagnetic and leakage current potential of the battery operated motor drive handle. Based on the results from these tests, it was concluded that the design performed equivalently to the predicate device and is suitable for its intended use.

In Vivo Tests

In vivo animal tests were performed to assess the performance of the Micro Therapeutics, Inc. Over the Wire (OTW) Thrombolytic Brush Catheter to that of a predicate device. The animal studies demonstrated that the OTW Thrombolytic Brush Catheter performed the same as the predicate device for percutaneous administration of pharmacologicals for dissolution of thrombus located in A-V fistulas.

Biocompatibility Tests

All components tested per ISO 10993-1.

Conclusion: The Micro Therapeutics, Inc. Over the Wire (OTW) Thrombolytic Brush Catheter is substantially equivalent to the predicate device based on the results of laboratory and animal testing.

00047

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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.

Rockville MD 20857

FEB - 6 1998

Mr. Brian Strauss Project Engineer Micro Therapeutics, Inc. 1062-F Calle Negocio San Clemente, CA 92673

K973669 Re: Over-the-Wire (OTW) Thrombolytic Brush Catheter Regulatory Class: II (two) Product Code: 74 MCW Dated: January 7, 1998 Received: January 9, 1998

Dear Mr. Strauss:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS-inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K973669

Device Name:

Micro Therapeutics Over the Wire (OTW) Thrombolytic Brush Catheter

Indications for Use:

If Micro Therapeutics, Inc. intends to recommend its Over the Wire (OTW) Thrombolytic Brush Catheter interface with specific pharmacological agents, Micro Micro Therapeutics will notify the Food and Drug Administration. Therapeutics, Inc. will not promote any such action until the Food and Drug Administration has reviewed and approved such action.

Administration has re

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(Division Sign-Off) Division of Cardiovascular. Respiratory. and Neurological Devic 510(k) Number _

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

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Over the Counter Use

000491

Regulation Number and Section

§ 870.4875 Intraluminal artery stripper.

(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).